Biopsy device

ABSTRACT

A biopsy device, primarily for cervical biopsy, comprising a generally arrowhead-shaped tool substantially V-shaped in cross section and having outer longitudinal knife edges intersecting at the sharp tip of the device. In use, the device is inserted into the tissue from which the specimen is to be taken. To separate the specimen from the adjacent tissue, a scalpel is run forwardly along longitudinal converging guide means- a groove or ribprovided on each inside face of the device just below each knife edge. The two converging guide grooves or ribs terminate at a central hole, which functions as a stop to limit forward movement of the scalpel. The separated specimen is thus held in the receptacle provided by the V-cross section tool, in which it is carried for removal from the body.

United States Patent 72] inventor Mario Enrique Jascalevich 435 60thSt., West New York, NJ. 07093 [21 1 Appl. No. 751,948

221 Filed Aug. 12, 1968 [45] Patented June 8,1971

[54] BIOPSY DEVICE 14 Claims, 7 Drawing Figs.

[52] US. Cl 128/2, 30/279, 30/287, 128/305 [51] Int. Cl A6lb 10/00, A61b17/32 [50] Field of Search 128/1, 2 B,

305, 305.5, 311, 303.14, 314, 329; 30/25, 286, Des. 83/12. 287, 294,279, 289; 144/1363; 145/25, 122, 24

[56] References Cited UNITED STATES PATENTS 440,705 1 1/1890 Gates30/25UX 622,461 4/1899 .lacquet et a1.. 145/24 627,647 6/1899 Lamont145/24 1,020,753 3/1912 Ford 128/314 1,489,603 4/1924 Kracht 128/305X2,010,590 8/1935 Grumbacher. 145/24X 2,098,123 11/1937 Wood 30/2872,540,393 2/1951 Hawley 30/25 2,865,374 12/1958 Brown et al 128/3053,007,471 11/1961 McClure, Jr 128/2 3,256,874 6/1966 DeMarco 128/2FOREIGN PATENTS 4,160 0/1901 Great Britain 128/314 158,983 7/1962U.S.S.R. 1281305 OTHER REFERENCES Hallac, 1., Surgery Apr. 1962, Vol.51, No. 4, pp. 515- 517, (copy in Gr. 335, 128/2B) PrimaryExaminer-Richard A. Gaudet Assistant Examinerl(yle L. HowellAttorneyl*larry G. Shapiro ABSTRACT: A biopsy device, primarily forcervical biopsy, comprising a generally arrowhead-shaped toolsubstantially V- shaped in cross section and having outer longitudinalknife edges intersecting at the sharp tip of the device. In use, thedevice is inserted into the tissue from which the specimen is to betaken. To separate the specimen from the adjacent tissue, a scalpel isrun forwardly along longitudinal converging guide means a groove or ribprovided on each inside face of the device just below each knife edge.The two converging guide grooves or ribs terminate at a central hole,which functions as a stop to limit forward movement of the scalpel. Theseparated specimen is thus held in the receptacle provided by the V-cross section tool, in which it is carried for removal from the body.

BIOPSY DEVICE BACKGROUND OF THE INVENTION This invention relates totaking biopsy specimens, particularly of the uterine cervical area. Intesting for carcinoma of the uterus, the critical area is the entranceto the cervix-the squamous columnar junction. It is here that 90 percentof uterine cancer is present.

The exposed tissue at this area, called the epithelium, is the criticallayer of tissue which it is desired to test for cancer, together withsome of the underlying tissue called the stroma which is examined fordepth of cancer spread, if any.

Presently used techniques have various disadvantages. For example, inone known technique, a punch is employed. The punch removes a completecircumferential ring of tissue from the cervical canal, and cuts in fromthe canal itself through the epithelium. Taking a complete ring oftissue is undesirable. One of the serious after effects can be closureof the cervical canal as a result of scar tissue fonnation. Cuttingthrough the epithelium lined canal is undesirable as the biopsyinstrument preferably should not touch the surface of the tissue to beexamined.

Another technique involves using an ordinary surgeon s knife or scalpelto cutoff a segment of the cervix at the canal entrance. However, inthis technique, the surgeon is unable to control the depth of the cut,and it is extremely difficult to retrieve the cut sample.

Other techniques have one or more of the various foregoingdisadvantages.

SUMMARY OF THE INVENTION The biopsy device of the present inventioncomprises a generally pointed instrument having converging side knifeedges. The device is shaped to provide a recess or receptacle fordefining and holding the biopsy sample. In the preferred form of theinvention, the recess or receptacle is provided by virtue of theinstrument being substantially V-shaped in transverse cross section.

In use, the device is inserted into the tissue area from which a biopsyspecimen is to be taken. For example, for a cervical biopsy, it isinserted into the cervical wall just below the epithelial surface to besampled. Then, to cut the specimen free, a scalpel is run forwardlyalong a guide groove or rib provided on each of the two opposed insideconverging faces of the instrument just below and parallel to theadjacent knife edges. The forward cutting movement of the scalpel isautomatically stopped by a hole at which the two converging guidegrooves or ribs meet.

The specimen has now been cut free, and is held in the recess of theinstrument by which it is carried outside the body for examination.

It is therefore the primary object of the present invention to provide anovel biopsy device.

It is a further object to provide a biopsy device which will not touchthe surface of the tissue to be sampled.

It is a further object to provide a biopsy device which will avoidtaking a completely annular specimen, but will rather take multipleselective transverse specimens.

It is a further object to provide a biopsy device the use of which willpromote rapid healing of the area from which the specimen is taken.

It is a further object to provide a biopsy device which providesaccurate control of the specimen taken even though the surgeon cannoteasily see the biopsy area.

The above and other objects, advantages, and features of the inventionwill become apparent to those skilled in the art from the followingdetailed description of preferred embodiments of the invention when readin conjunction with the accompanying drawing.

DESCRIPTION OF THE FIGURES FIG. 1 is a top plan view of the novel biopsydevice of the invention.

FIG. 2 is a elevational view looking in a longitudinal direction fromthe rear toward the front of the device.

FIG. 3 is a longitudinal sectional view taken on line 3-3 of FIG. 1.

FIG. 4 is a partial transverse sectional view taken on line 44 of FIG.3, showing one of the grooves for guiding a scalpel to cut off one sideof the biopsy sample.

FIG. 5 is a view similar to FIG. 4 of a modified form of the inventionin which ribs are employed instead of grooves.

FIG. 6 is a side elevational view of the uterine-cervical area of thebody, showing the technique of using the biopsy device of the invention.

FIG. 7 is an enlarged front view of FIG. 6, further showing a scalpelcutting through one side of the biopsy sample.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the drawing, thereference numeral 2 designates a handle to which the biopsy device 4 ofthe present invention is attached. Handle 2 may be of any suitable sizeand shape. The device 4 may be permanently or removably attached to thehandle.

The biopsy device 4 itself, as best seen in FIGS. 1 and 2, comprises twothin-walled flat or planar sections 6 and 8 which are disposed at anangle to each other and intersect along a central longitudinal line 10.Preferably the dihedral angle between sections 6 and 8 is approximatelydegrees, as shown in FIG. 2.

The respective outer side edges 12 and 14 of sections 6 and 8 are eachsharpened to a fine cutting knife edge. Knife edges 12 and 14 convergeforwardly and downwardly to meet at'and form the sharp tip 16 of thedevice.

It will be seen from the foregoing description that the biopsy device 4is generally like an arrowhead in overall shape. Further, the angularlydisposed sections 6 and 8 making up the body of the device provide it inthe form of a recess or receptacle which is generally wedge-shaped. Aswill be described shortly, this receptacle aspect of the inventiongreatly simplifies retention of the cut biopsy sample and its removalfrom the body.

Guide means are provided to control movement of a scalpel alongpredetermined paths to sever the biopsy specimen from the adjacenttissue. Such guide means comprises guide grooves 18 and 20 provided onthe respective opposed inside faces of sections 6 and 8. Grooves I8 and20 are parallel with and closely adjacent to the related knife edges 12and 14 respectively. The converging grooves terminate at a small hole 22formed on centerline 10 adjacent tip 16. Hole 22 automatically stops thescalpel being moved forwardly along groove 18 or 20.

As shown in FIG. 5, raised ribs 24 may be employed as the scalpel guidemeans instead of the depressed grooves 18, 20. Here, the scalpel is heldpressed downwardly and against the rib so as to be guided thereby in itsforward movement.

The device 2 is made of any suitable material, e.g., stainless steel. Itcan be fabricated by any suitable techniques. For example, it can beformed as an integral device by first stamping a blank of theappropriate shape, which is then bent and other wise worked, andsharpened, to produce the final device.

A typical use of the biopsy device of the invention for taking acervical epithelial specimen will now be described. Referring to FIGS. 6and 7, numeral 26 designates the cervix and 28 the cervical canal. Thedevice is held by handle 4 and inserted tip first into the cervical areajust underlying the section of epithelial cervical canal tissue to besampled. The device is inserted to the desired depth, the penetrationbeing facilitated by the sharp tip 16 and the sharp knife edges 12, 14.Then, the surgeon places the cutting edge of a scalpel 30 (FIG. 7) onthe exposed (nonpenetrating) portion of groove 18 or 20 and runs thescalpel forwardly along the groove until the scalpel is automaticallystopped by reaching hole 22. This stopping is further signalled to thesurgeon by virtue of the different sensation that he feels through hisfingers when the scalpel hits the hole.

This step has cleanly severed one side of the biopsy specimen from theadjacent tissue without jagged edges. The surgeon then repeats theprocess using the other groove, whereby the specimen has now beencompletely separated from the ad joining tissue, and is held in thereceptacle provided by the V cross section of the biopsy device.

It should be noted that the cutting path, and its length and depth, ofthe scalpel 30 to sever the sides of the specimen are accurately guidedand controlled by the guide grooves 18, (or ribs 24), and the stop hole22, even though the surgeon is cutting essentially blind into thetissue.

The device 2 carrying the specimen within it is now removed from thebody and the specimen then removed for examination.

Usually, four, but possibly more, specimens will be taken at spacedlocations around the cervical canal, This provides a good sampling whileleaving bridges of tissue intact to facilitate healing without thedanger of stricture or closing of the canal by scar tissue formation aswould be likely if a completely annular sample or set of tissue sampleswere taken.

The fact that the tissue specimen taken by the present device iswedge-shaped is advantageous for several reasons. For one thing, thisshape enables the surgeon to determine by mere visual inspection of thespecimen its orientation, i.e., which is the more significant epithelialface and which is the less significant, underlying stroma. The largebroadest surface of the specimen will of course be the exposedepithelium of the cervical canal, while the narrow tapering portion willbe the stroma. Further, the wedge-shaped inwardly tapering crevice leftby the removal of the specimen helps facilitate healing.

While intended primarily for cervical biopsy, the principles of thepresent invention can also advantageously be used for biopsy of otherportions of the body, eg, the surface of the ovaries, the uterus, liver,kidney, lung, etc.

While there have been shown and described two preferred embodiments ofthe invention, it will be understood and apparent to those skilled inthe art that numerous variations and modifications, in form andapplication, can be made without departing from the spirit and scope ofthe invention and its features. Accordingly, it is intended that theforegoing disclosure be exemplary only, and not in any way limitative ofthe following claims.

I claim:

1. In a biopsy instrument, a generally pointed device having convergingcutting knife edges, means defining a receptacle between said knifeedges comprising two substantially flat planar portions disposed at anangle to each other intersecting along a longitudinally extending lineto provide a tapered, substantially V-shape in transverse cross section,said converging cutting knife edges being respectively positioned at theoutermost longitudinal edges of the planar portions, and means disposedbetween the knife edges for guiding a cutting tool.

2. The combination according to claim 1 wherein said knife edges aresubstantially linear and meet at the point of said device to from asharp tip.

3. The combination according to claim 2 wherein the knife edges and saidlongitudinally extending line meet at said tip.

4. The combination according to claim 3 wherein said angle issubstantially a right angle.

5. The combination according to claim 1 including means for stoppingmovement of a cutting tool.

6. The combination according to claim 5 wherein said guide meanscomprises elongated groove means provided on said planar portions.

7. The combination according to claim 6 wherein said groove meanscomprises converging grooves, one disposed adjacent each knife edge.

8. The combination according to claim 7 wherein stopping means comprisesmeans defining a hole in device, said converging grooves terminating atsaid hole.

9. The combination according to claim 6 wherein stopping means comprisesmeans defining a hole in device. g

10. The combination according to claim 5 wherein said guide meanscomprises elongated rib means provided on said planar portions.

11. The combination according to claim 10 wherein said rib meanscomprises converging ribs, one disposed adjacent each knife edge.

12. The combination according to claim 11 wherein said stopping meanscomprises means defining a hole in said device, said converging ribsterminating at said hole.

13. The combination according to claim 10 wherein said stopping meanscomprises means defining a hole in said device.

14. The combination according to claim 5 wherein stopping meanscomprises means defining a hole in device.

said said said said said said

1. In a biopsy instrument, a generally pointed device having convergingcutting knife edges, means defining a receptacle between said knifeedges comprising two substantially flat planar portions disposed at anangle to each other intersecting along a longitudinally extending lineto provide a tapered, substantially V-shape in transverse cross section,said converging cutting knife edges being respectively positioned at theoutermost longitudinal edges of the planar portions, and means disposedbetween the knife edges for guiding a cutting tool.
 2. The combinationaccording to claim 1 wherein said knife edges are substantially linearand meet at the point of said device to from a sharp tip.
 3. Thecombination according to claim 2 wherein the knife edges and saidlongitudinally extending line meet at said tip.
 4. The combinationaccording to claim 3 wherein said angle is substantially a right angle.5. The combination according to claim 1 including means for stoppingmovement of a cutting tool.
 6. The combination according to claim 5wherein said guide means comprises elongated groove means provided onsaid planar portions.
 7. The combination according to claim 6 whereinsaid groove means comprises converging grooves, one disposed adjacenteach knife edge.
 8. The combination according to claim 7 wherein saidstopping means comprises means defining a hole in said device, saidconverging grooves terminating at said hole.
 9. The combinationaccording to claim 6 wherein said stopping means comprises meansdefining a hole in said device.
 10. The combination according to claim 5wherein said guide means comprises elongated rib means provided on saidplanar portions.
 11. The combination according to claim 10 wherein saidrib means comprises converging ribs, one disposed adjacent each knifeedge.
 12. The combination according to claim 11 wherein said stoppingmeans comprises means defining a hole in said device, said convergingribs terminating at said hole.
 13. The combination according to claim 10wherein said stopping means comprises means defining a hole in saiddevice.
 14. The combination according to claim 5 wherein said stoppingmeans comprises means defining a hole in said device.